PregnancyNCT02268877
A Randomized Prospective Analysis of Time to Diagnosis and Length of Stay of Emergency Department Pelvic Ultrasonography
A study testing Emergency Medicine Physician Ultrasound and Ultrasound in people with Pregnancy, run by Denver Health and Hospital Authority.
Trial summary
The goal of this project is to compare the efficiency of pelvic ultrasounds performed by emergency medicine residents and attending physicians to the efficiency of pelvic ultrasounds performed by the department of radiology. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Emergency Medicine Physician Ultrasound and Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- have a positive serum or urine beta-human chorionic gonadotropin (hCG)
- estimated gestational age (EGA) of less than 20 weeks
- complaint of pelvic pain and/or vaginal bleeding
Who cannot join
- prior known documentation of an intrauterine pregnancy
- estimated gestational age (EGA) of greater than 20 weeks
- peritoneal findings on physical examination
- unstable vital signs as deemed appropriate by the attending physician
- prisoners
- open cervix upon physical examination
About this study
The goal of this project is to compare the efficiency of pelvic ultrasounds performed by emergency medicine residents and attending physicians to the efficiency of pelvic ultrasounds performed by the department of radiology.
Read the detailed description
This study is a randomized, prospective interventional study of pregnant patients presenting to the emergency department with complaints of pelvic pain and/or vaginal bleeding. This study will be conducted at 4 sites across the United States. Patients who are eligible and consent to participate will be randomized to one of two conditions; 1) a pelvic ultrasound that is performed by a certified emergency department attending or physician, or 2) a pelvic ultrasound that is performed by a certified radiology technician (standard-of-care). The time to diagnosis and emergency department length of stay between the two groups will be compared.
- Conditions
- Pregnancy
- Being tested
- Emergency Medicine Physician Ultrasound, Ultrasound
- Keywords
- ultrasonography, emergency department
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency Medicine Physician UltrasoundOther
An ultrasound will be performed by an emergency medicine resident or attending physician
UltrasoundDevice
An ultrasound will be performed by a radiology department technician
| Study group | Role | What they receive |
|---|---|---|
| Emergency Medicine Physician Ultrasound | Experimental | Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound. Receives: Other: Emergency Medicine Physician Ultrasound; Device: Ultrasound |
| Radiology Tech Ultrasound | Active comparator | Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care. Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Definitive Diagnosis
The time the patient is placed in room to the time that results of the ultrasound (and/or consultative impression made by radiology or obstetrics and gynecology) are documented in patient chart
Measured: 24 hours
Emergency Department Length-of-Stay
The time the patient is placed in room to the time that the patient is discharged/admitted.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startMar 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Collaborators
- United States Naval Medical Center, Portsmouth, United States Naval Medical Center, San Diego, University of Colorado, Denver
- Responsible party
- Sponsor
- Investigators
- John Kendall, MD, Principal investigator, Denver Health and Hospital Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268877
- Sponsor's protocol ID
- 11-1444
- Status last verified
- Jun 2017
- First submitted
- 16 Oct 2014
- Last updated
- 27 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kendall JL, Hoffenberg SR, Smith RS. History of emergency and critical care ultrasound: the evolution of a new imaging paradigm. Crit Care Med. 2007 May;35(5 Suppl):S126-30. doi: 10.1097/01.CCM.0000260623.38982.83.
PubMed 17446770Durham B, Lane B, Burbridge L, Balasubramaniam S. Pelvic ultrasound performed by emergency physicians for the detection of ectopic pregnancy in complicated first-trimester pregnancies. Ann Emerg Med. 1997 Mar;29(3):338-47. doi: 10.1016/s0196-0644(97)70345-7.
PubMed 9055772Burgher SW, Tandy TK, Dawdy MR. Transvaginal ultrasonography by emergency physicians decreases patient time in the emergency department. Acad Emerg Med. 1998 Aug;5(8):802-7. doi: 10.1111/j.1553-2712.1998.tb02507.x.
PubMed 9715242Dart RG. Role of pelvic ultrasonography in evaluation of symptomatic first-trimester pregnancy. Ann Emerg Med. 1999 Mar;33(3):310-20. doi: 10.1016/s0196-0644(99)70368-9.
PubMed 10036346Tayal VS, Cohen H, Norton HJ. Outcome of patients with an indeterminate emergency department first-trimester pelvic ultrasound to rule out ectopic pregnancy. Acad Emerg Med. 2004 Sep;11(9):912-7. doi: 10.1197/j.aem.2004.03.017.
PubMed 15347539Blaivas M, Sierzenski P, Plecque D, Lambert M. Do emergency physicians save time when locating a live intrauterine pregnancy with bedside ultrasonography? Acad Emerg Med. 2000 Sep;7(9):988-93. doi: 10.1111/j.1553-2712.2000.tb02088.x.
PubMed 11043992Shih CH. Effect of emergency physician-performed pelvic sonography on length of stay in the emergency department. Ann Emerg Med. 1997 Mar;29(3):348-51; discussion 352. doi: 10.1016/s0196-0644(97)70346-9.
PubMed 9055773
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Analysis of Time to Diagnosis and Length of Stay of Emergency Department Pelvic Ultrasonography
- ClinicalTrials.gov ID
- NCT02268877
- Acronym / sponsor ID
- 11-1444
- Conditions
- Pregnancy
- Keywords
- ultrasonography, emergency department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Collaborators
- United States Naval Medical Center, Portsmouth, United States Naval Medical Center, San Diego, University of Colorado, Denver
- Study start
- Mar 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Posted 31 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is to compare the efficiency of pelvic ultrasounds performed by emergency medicine residents and attending physicians to the efficiency of pelvic ultrasounds performed by the department of radiology.
Detailed description
This study is a randomized, prospective interventional study of pregnant patients presenting to the emergency department with complaints of pelvic pain and/or vaginal bleeding. This study will be conducted at 4 sites across the United States. Patients who are eligible and consent to participate will be randomized to one of two conditions; 1) a pelvic ultrasound that is performed by a certified emergency department attending or physician, or 2) a pelvic ultrasound that is performed by a certified radiology technician (standard-of-care). The time to diagnosis and emergency department length of stay between the two groups will be compared.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emergency Medicine Physician Ultrasound | Experimental | Other: Emergency Medicine Physician Ultrasound, Device: UltrasoundPatients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound. |
| Radiology Tech Ultrasound | Active comparator | Device: UltrasoundPatients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- have a positive serum or urine beta-human chorionic gonadotropin (hCG)
- estimated gestational age (EGA) of less than 20 weeks
- complaint of pelvic pain and/or vaginal bleeding
Key exclusion criteria (6 listed)
- prior known documentation of an intrauterine pregnancy
- estimated gestational age (EGA) of greater than 20 weeks
- peritoneal findings on physical examination
- unstable vital signs as deemed appropriate by the attending physician
- prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergency Medicine Physician UltrasoundAn ultrasound will be performed by an emergency medicine resident or attending physician | Other | Emergency Medicine Physician Ultrasound |
| UltrasoundAn ultrasound will be performed by a radiology department technician | Device | Emergency Medicine Physician Ultrasound, Radiology Tech Ultrasound |
Primary outcome
Time to Definitive Diagnosis
Time frame: 24 hours
The time the patient is placed in room to the time that results of the ultrasound (and/or consultative impression made by radiology or obstetrics and gynecology) are documented in patient chart
Emergency Department Length-of-Stay
Time frame: 48 hours
The time the patient is placed in room to the time that the patient is discharged/admitted.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17446770Kendall JL, Hoffenberg SR, Smith RS. History of emergency and critical care ultrasound: the evolution of a new imaging paradigm. Crit Care Med. 2007 May;35(5 Suppl):S126-30. doi: 10.1097/01.CCM.0000260623.38982.83.
- Results publication: PubMed 9055772Durham B, Lane B, Burbridge L, Balasubramaniam S. Pelvic ultrasound performed by emergency physicians for the detection of ectopic pregnancy in complicated first-trimester pregnancies. Ann Emerg Med. 1997 Mar;29(3):338-47. doi: 10.1016/s0196-0644(97)70345-7.
- Results publication: PubMed 9715242Burgher SW, Tandy TK, Dawdy MR. Transvaginal ultrasonography by emergency physicians decreases patient time in the emergency department. Acad Emerg Med. 1998 Aug;5(8):802-7. doi: 10.1111/j.1553-2712.1998.tb02507.x.
- Results publication: PubMed 10036346Dart RG. Role of pelvic ultrasonography in evaluation of symptomatic first-trimester pregnancy. Ann Emerg Med. 1999 Mar;33(3):310-20. doi: 10.1016/s0196-0644(99)70368-9.
- Results publication: PubMed 15347539Tayal VS, Cohen H, Norton HJ. Outcome of patients with an indeterminate emergency department first-trimester pelvic ultrasound to rule out ectopic pregnancy. Acad Emerg Med. 2004 Sep;11(9):912-7. doi: 10.1197/j.aem.2004.03.017.
- Results publication: PubMed 11043992Blaivas M, Sierzenski P, Plecque D, Lambert M. Do emergency physicians save time when locating a live intrauterine pregnancy with bedside ultrasonography? Acad Emerg Med. 2000 Sep;7(9):988-93. doi: 10.1111/j.1553-2712.2000.tb02088.x.
- Results publication: PubMed 9055773Shih CH. Effect of emergency physician-performed pelvic sonography on length of stay in the emergency department. Ann Emerg Med. 1997 Mar;29(3):348-51; discussion 352. doi: 10.1016/s0196-0644(97)70346-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Kendall, MD principal investigator
Denver Health and Hospital Authority
Questions about this trial
What is this clinical trial studying?
A study testing Emergency Medicine Physician Ultrasound and Ultrasound in people with Pregnancy, run by Denver Health and Hospital Authority.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Definitive Diagnosis (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02268877, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2017.